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FDA 510(k)

AquaPulse Irrigation Tubing

K-Number: K202560 · 2020-12-10

ApplicantGa Health Company Limited
Decision Date2020-12-10
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AquaPulse Irrigation Tubing is a medical device manufactured by Ga Health Company Limited. It received FDA 510(k) clearance on 2020-12-10 under approval number K202560. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AquaPulse Irrigation Tubing?

AquaPulse Irrigation Tubing is a medical device that received FDA 510(k) clearance on 2020-12-10. It is manufactured by Ga Health Company Limited. The 510(k) number is K202560.

When was AquaPulse Irrigation Tubing approved by the FDA?

AquaPulse Irrigation Tubing received FDA 510(k) clearance on 2020-12-10, under approval number K202560.

What company makes AquaPulse Irrigation Tubing?

AquaPulse Irrigation Tubing is manufactured by Ga Health Company Limited.

What is the FDA product code for AquaPulse Irrigation Tubing?

The FDA product code for AquaPulse Irrigation Tubing is OCX.

Other Devices by Ga Health Company Limited

K200495Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve K200481Andorate Biopsy Valve, Andorate Biopsy Irrigator K200479AquaPulse Auxiliary Water Connector K200388Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector K202838Andorate Universal Endoscope Tip Guard K223171AquaPulse® Irrigation Tubing

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Related Devices (Code: OCX)

K161167Seal Single-Use Biopsy ValveEndochoice, Inc. K152278ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. K182275Seal Single Use Biopsy ValveBoston Scientific Corporation K181509Endorate Valve SetsSmartdata Suzhou Co., Ltd. K173758Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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